BUSCOPAN

What it is

BUSCOPAN is a medicine containing hyoscine butylbromide, available as tablets containing 10 mg per tablet, BUSCOPAN FORTE tablets containing 20 mg per tablet, and ampoules containing 20 mg per 1 mL. BUSCOPAN is a quaternary ammonium anticholinergic agent with a ganglion blocking component that reduces the tone and peristalsis of smooth muscle in hollow organs with parasympathetic innervation.

Approved indications

— Spasm of the gastrointestinal tract (tablets) — Spasm of the gastrointestinal tract (ampoules) — Biliary spasm (ampoules) — Renal spasm (ampoules) — Diagnostic aid in radiology (ampoules)

Dosing overview

For adults and children over 6 years, the dose is 2 BUSCOPAN tablets (2 × 10 mg) four times daily, or 1 BUSCOPAN FORTE tablet (1 × 20 mg) four times daily. BUSCOPAN tablets are not recommended for children under 6 years of age. For ampoules, the dose is 1 or 2 ampoules (20 or 40 mg) by intramuscular or slow intravenous injection, with a maximum daily dose of 100 mg. BUSCOPAN tablets and ampoules should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

Key safety warnings

In case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting or blood in stool, medical advice should immediately be sought. Hyoscine may cause drowsiness and patients so affected should not drive or operate machinery, and should abstain from alcohol. Elevation of intraocular pressure may be produced by BUSCOPAN in patients with undiagnosed narrow-angle glaucoma, and patients should seek urgent ophthalmological advice if they develop a painful, red eye with loss of vision after an injection. After parenteral administration, cases of anaphylaxis including episodes of shock have been observed, and patients receiving BUSCOPAN by injection should be kept under observation. Patients with cardiac conditions undergoing parenteral treatment with BUSCOPAN ampoules should be monitored, as BUSCOPAN can cause tachycardia, hypotension and anaphylaxis, and emergency equipment and personnel trained in its use must be readily available.

Contraindications

BUSCOPAN is contraindicated in patients with known hypersensitivity to hyoscine butylbromide or any excipients, mechanical stenosis in the gastrointestinal tract, achalasia, paralytic or obstructive ileus, intestinal atony, prostatic hypertrophy with urinary retention, myasthenia gravis, glaucoma, pathological tachyarrhythmias, and megacolon. BUSCOPAN should not be given to patients with porphyria. By intramuscular injection, BUSCOPAN ampoules are contraindicated in patients being treated with anticoagulant drugs, though intravenous routes may be used in these patients.

Regulatory history

BUSCOPAN ampoules (20 mg/1 mL injection) were first listed on the ARTG on 26 September 1991. BUSCOPAN tablets (10 mg) were first listed on the ARTG on 3 August 1994. BUSCOPAN FORTE tablets (20 mg film-coated) were first listed on the ARTG on 9 July 2008.